Running a medical device or IVD clinical study involves dozens of activities across three phases: preparation, enrolment, and close-out. A team carries out the work, but someone has to know what must happen, when, and who is responsible. That is clinical project management, and it is the part of a study less experienced Study Sponsors...

The US Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) has published the user fees applicable to submissions, etc for fiscal year 2027, running from 1 October 2026 to 30 September 2027. The new fees represent between a 10% and 20% increase over the 2026 fees. Further details are available from…

Donawa Lifescience has launched the Donawa InTeam flexible clinical staffing service to provide medical device and IVD companies fast access to qualified clinical professionals — Clinical Project Managers, Clinical Research Associates and Clinical Study Assistants — who join the client’s team on a fixed assignment, with none of the delays typically associated with recruitment. Through Donawa…

The US Food and Drug Administration (FDA) has released draft wording for a new rule that would allow gretaer use of electronic instructions for use for many types of medical device. The proposed rule, if finalized, would clarify that the “adequate directions for use” requirement under section 502(f) of the Federal Food, Drug, and Cosmetic…

The US Food and Drug Administration has recently published a Q&A document on the subject of Clinical Support Software, following release of full guidance on the topic in January 2026. The Q&A explains that “Clinical Decision Support (CDS) software are important tools in modern health care. While some CDS software has been excluded from the…